While the British government awaits a UK Supreme Court ruling over whether Prime Minister Boris Johnson misled the Queen over the proroguing of Parliament, the Ursula von der Leyen team of would-be Commissioners await their turn for a grilling by MEPs, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

The European Parliament currently plans to hold two hearings on 30 September, six on 1 October, another six on both 2 and 3 October, and three on 7 October.

The three proposed Commission executive vice–presidents will take their turns on 8 October, with the final vote on the entire Commission planned for 23 October.

As well as facing tough questioning from deputies, von der Leyen and some candidates could also be questioned by law enforcement authorities and parliamentary committees undertaking investigations. It’s generally thought that not every candidate will survive the process (we’re talking about Rovana Plumb(Romania), Poland’s Janusz Wojciechowski and Hungary’s László Trócsányi).

Even without such looming shadows, the hurdles for commissioners-designate to vault over are high. European Parliament rules require a majority of at least two thirds among the most influential MEPs, which meansthe political groups’ committee coordinators, for an immediate ‘pass’.

The rules state that: “If co-ordinators cannot reach a majority of at least two-thirds of the committee membership to approve the candidate”, he or she mustanswer additional questions in written form or reappear before the committee. If a two-thirds majorityis still not reached, a simple majority in a full committee vote wouldusuallysuffice.

Even before the upcoming grilling for each, it seems all is not well. Green MEPKarima Delli, who is chair of the transport committee, this week gaineda significant majority backing a request that Parliament send a letter to the Commission president-elect calling for the renamingof Vice President-designate Margaritis Schinas’ portfolio, currently titled “protecting the European way of life” and which includes the migration file.

Delli waded straight in and called itan “insult to EU values”. Oopsie! Let’s see where that goes…

New jobs for the…ladies

Meanwhile, Denmark’s Margrethe Vestager is in charge of “a Europe fit for the digital age”, which means she has plenty to oversee, not least in the realm of the sharing of important medical data in the personalised medicine age, including genomes exchanges and, of course, e-health records.

Elevating three executive vice-presidents from an eight-strong group of VPs is without doubt the biggest structural change that von der Leyen announced earlier this week, at the same time as describing her Commission as a “geopolitical” one.

As one commissioner-designate put it (Valdis Dombrovskis, who is a former prime minister of Latvia), the von der Leyen Commission aims “to be leaders rather than followers” in light of an expected “radical transformation” of EU economies and societies.

Dombrovskis has a huge portfolio, handling: “economy, social policy, social dialogue, investment…financial stability, financial services”. Good luck with all that, Valdis.

Incoming Health Commissioner Stella Kyriakides (Cyrpus) has already, we’re happy to note, emphasized priorities includingthe supply of affordable medicines, the implementation of the new medical devices regulation,and the creation of a European Health Data Space.

She also highlighted antimicrobial resistance, vaccination and a European plan to beat cancer.

As promised, vdL has tasked Kyriakides with formulating the cancer plan, which would support Member States in improvingprevention and care.

Meantime, Bulgarian Commissioner Mariya Gabriel will take the innovation and youth portfolio for her second stint in the Berlaymont. This covers research policyand the Horizon Europe programme. Go Mariya!

EAPM joins the show

And in the heart of EAPM Land, the Alliance is organising a roundtable on 8 October from 8h onwards in the European Parliament, not long after major meeting we’ll be holding at the ESMO Congress in Barcelona.

Said EAPM Executive Director Denis Horgan: “Of course, we’ll be walking the hallways to the MEPs’ offices long before the meeting, but this roundtable in early October obviously comes at an important time.

“Topics up for discussion on the morning of the 8th will include time given our planned, ongoing engagement with certain new commissioners,” Horgan explained.

He went on to emphasize that the crucial topics on the table at the morning meeting on the 8th will include realizing the potential in the declaration of cooperation for the One Million Genomes project,with a focus on the issues relating to real–world evidence.

Also up for discussion will be cancer and rare diseases,with a specific focus on lung and prostate cancers,in terms of early diagnosis.

Linked to the above will be the subject of molecular diagnostics and biomarkers with a view to formulating a workable framework to facilitate their optimal use, and what Denis describes as “positioning EU leadership in the area of personalised health care”. AI is also on the table for the gathering.

Survival rates on the up

And while we’re talking about cancer, survival rates have been improving over two decades in a number of developed countries, including some in the EU, according to a report published by the International Agency for Research on Cancer.

The report says that “Over 1995–2014, one–year and five–year net survival increased in each country across almost all cancer types,” and added that five-year rectal cancer survival increased more than 13%in Denmark, Ireland, and the UK.

The report’s authors say that these improvements probably result from major healthcare reforms and technological advances enabling earlier diagnosis, plus more effective and tailored treatment;, as well as better patient management.

And finally…

When the chips are down, or in this case up, you can always count on your elected representatives to swing into action. Are you sitting down? Because here comes a real scandal – the cost of French fries in the MEPs’ Brussels canteen has risen.

Yes, we know. it beggars belief. Especially as chips are fattening, right?

Read this shocked and outraged message from the staff committee, which we reproduce here (with due-and-fair warning to frite-heads everywhere): “On 5 August, when most of us were away on holiday, canteen prices in Brussels skyrocketed.

“The average price hike was 12% overnight.And over the last two years, some products have got way more expensive. Coffee has gone up 25%, salad 37% and French fries a massive 67%. In Belgium!”

Armin Machmer, Parliament’s director of logistics (which includes the canteens), will appear before the staff committee next week to answer questions about the price hikes.

Doubtless von der Leyen will be watching the process from afar with considerable interest. Bon appétit!

The October 2010 Declaration called on the Commission and/or member states to:

Ensure that there is adequate mapping and funding of, and increased co-operation in, cancer research;

develop a holistic cancer research strategy based on a matrix, with horizontals such as transnational research and diagnosis and verticals such as research on prevention, research on screening and research on quality of life and care;

utilize the European Partnership for Action Against Cancer to organize different research working groups, and;

promote partnerships with patient groups, harnessing their specific expertise and knowledge to support accelerated progress in research.

Much has been achieved since then, of course, with aspects becoming part of the personalised medicine sector as well as applying to cancer. For example on last year’s Declaration on the EU-wide one-million genomes project.

Now that the Cypriot commissioner-designate has been given the health brief, it’s all to the good. As a trained clinical psychologist, campaigner on breast cancer and health policymaker in Nicosia, she certainly has the background for the job.

Von der Leyen said today: ““This will be a Commission that walks the talk. We have a structure that focuses on tasks not hierarchies. We need to be able to deliver on the issues that matter the most rapidly and with determination.”

We wait to see how much the re-structuring means in respect of making health a higher or lower priority.

Of course, the list below is of nominees, with each having to face oral and written questions from the European Parliament, before MEPs approve their passage into their new posts. Timelines suggest these hearings will take place at the end of this month and into early October.

The nominees need to be properly prepared, as history has taught us that these Parliamentary hearings can turn into a bit of a grilling…although no one expects the Spanish Inquisition.

Meanwhile, some 40 health NGOs have published a job advertisement for a European Commissioner for Health, stating that whoever lands the post has to “set the vision and strategy for reducing inequalities in health across the EU”.

The organizations want the health commissioner to “prioritize the public interest over those of economic and financial actors by, among other things, limiting meetings with corporate lobbyists and ensuring that meetings that do take place are transparent”.

The next European Commission nominees

Austria’s Johannes Hahn is a former science minister who set up a national ‘Award of Excellence’for the best doctoral thesis in Austria(despite much-reported challenges over his own PhD). He is the ex-CEO of betting company Novomatic. Hopefully not a gamble for vdL.

Belgium has nominated Didier Reynders, who has acted as minister for finance (during the launch of the euro), and for foreign affairs. Belgium is punching above its weight this time around, being also represented elsewhere with Charles Michel set to become Council chief.

Bulgaria has Mariya Gabriel, who has already served in the Commission by heading up the digital economy and society team. Mariya was an MEP from 2009 to 2017, becoming MEP of the Yeartwice. Now put in charge of the Innovation and Youth brief, she’s an ex-teacher and researcher, as well as a fan of bees and Twitter. Stinging remarks shouldn’t be a problem, then.

Croatia’s nominee Dubravka Šuicahas ‘mayor of Dubrovnik’ written on her CV. She’s also a former teacher of German (handy given her new boss), and has worked with EAPM during her more-recent time as an MEP. She’s been handed a vice-president role and the Democracy and Demography portfolio.

As mentioned, Cyprus has nominated Stella Kyriakides, who is described back home as a Mother Theresa figure – in the sense that she aims to help people but is not overly opinionated. In 2018, Stella pushed for a law decriminalizing abortion.

The Czech Republic, meanwhile, has Věra Jourováset to simply move offices in the Berlaymont in her new role as vice-president. She is currently responsible for justice, consumers and gender equality in the soon-to-depart Commission. Amusingly (or not), her life story has beencompared to a “dark version of Borgen”. Yikes!

Denmark is sticking with current Commissioner Margrethe Vestager who failed in her bid for the top job, but should do OK under vdL as an executive vice president and, crucially for us, in charge of co-ordinating the agenda on a Europe fit for the digital age. She’s an ex-cabinet minister and the main inspiration for the above-mentioned TV series Borgen, which we highly recommend (if you don’t mind subtitles).

Estonia’s Kadri Simson is known for being “always prepared” as well as “smiley”. She was brought up in the university town of TartuIn and, once in Tallinn, she led the Centre Party.

Finland’s nominee Jutta Urpilainen is a former finance minister (named Europe’s ‘fourth best’ in 2012) and onetime-leader of the Social Democrats. She will be Finland’s first female commissioner, and probably the first commissioner to have recorded a Christmas album. It was called Christmassy Thoughts and included Jutta’s versions of Winter Wonderland and Jingle Bells.

France, after a little delay, named Marseille’s Sylvie Goulard as its nominee. Briefly a defence minister, the former MEP was in the past part of the French team that negotiated on the reunification of Germany. Good work, Sylvie.

Greece’s nominee Margaritis Schinas was until recently the European Commission’schief spokesperson and has been parachuted straight in as a vice-president. He was an MEP between 2007 and 2009 and is known to dislike being called “a bureaucrat”. Hmm.

Hungary has put MEP László Trócsány iin the Berlaymont mix. He was Hungary’s justice minister from 2014-19 and has served as ambassador to Belgium and France. Said to beloyal to Prime Minister Viktor Orbán. Might be in for a rough ride at the hearings over a role as justice minister back home.

Ireland is sticking with current Commissioner Phil Hogan, who is thought of by the Fine Gael government as a shrewd deal-maker. By no means a fan of Brexit in general, and of Boris Johnson in particular. We’ll ask him his views on Guinness when we get the chance.

Italy has nominated its former prime minister Paolo Gentiloni. He’s also a former journalist, and ex-minister for foreign affairs and communications. Very elegant, well-mannered and diplomatic. Nicknamed er moviola, which translates as ‘slow-mover’ in the local Roman dialect.

Latviahas again offered up Valdis Dombrovskis, a former prime minister at home and an ex-lab assistant in Germany in a previous life. He’s a former MEP, too, who currently holds the Commission’s Euro and Social Dialogue brief, as well as being in charge of Financial Stability, Financial Services and Capital Markets Union. This time around he’s a Commission executive vice-president.

Lithuania has nominated Virginijus Sinkevičius, who is the youngest at just 28-years-old and has only been in politics since 2016. He is known for keeping a Donald Trump ‘Make America Great Again’hat in his office. This should be fun, especially if he meets Mariya Gabriel on Twitter…

Luxembourg has chosen Nicolas Schmit for the Berlaymont. He’s served as labour minister under governments led by both Jean-Claude Juncker and Xavier Bettel. He’s also worked opposite his new boss when von der Leyen held the same job in Germany.

Malta has nominated its first female Commissioner in Helena Dalli. She is, of course, a movie star (Final Justice), ex-Miss Malta winner and former Miss World contestant – all when her surname was Abela. Ms Dalli is also a onetime minister for social dialogue and EU affairs, and introduced the marriage equality bill in Valletta.

The Netherlands stays loyal to Frans Timmermans, who also missed out on the job of president, but will be an Executive Vice-President in Ushi’s team. He’s an ex-foreign minister who speaks several languages, and is also – like Juncker – the grandson of a coal miner. We hereby not-very-exclusively reveal that is wasn’t the same grandfather.

Poland brings us Janusz Wojciechowski as a late replacement for Krzysztof Szczerski (who withdrew as he didn’t want the agriculture portfolio). He’s a member of the European Court of Auditors, but ironically is currently being accused of irregularities over travel expenses.

Portugal’s (first-ever female) nominee is Elisa Ferreira, who is an economist and deputy governor of the Bank of Portugal. She’s served three terms as an MEP and was chosen as nominee ahead offormer Infrastructure Minister Pedro Marques. She’s got the job of leading on Cohesion and Reforms.

Romania has put forward just-elected MEP Rovana Plumb, who apparently is not exactly best friends with current Romanian Commissioner Corina Crețu. Ms Plumb is also Bucharest’s former EU funds minister.

Slovakia has nominated career diplomat Maroš Šefčovič as its commissioner. Maroš is apparently a big Star Trek fan who once told Politico to “Live long and prosper”. Let’s hope he shows, ahem, enterprise. He’ll have plenty of chance, as he retains a role as vice-president.

Slovenia’s nominee Janez Lenarčič is another career diplomat, who has served as Ljubljana’s ambassador to the OSCE, director of the OSCE’s Office for Democratic Institutions and Human Rights, and as secretary of Slovenia’s permanent UN mission. He was a right-hand man to ex-Prime Minister Janez Drnovšek.

Spain has put forward Josep Borrell, who some may remember as Spain’s representative in Valery Giscard d’Estang’s ultimately failed Convention on the future of Europe back in 2002, as well as in his job as a former European Parliament president.

Sweden, meanwhile, gives us Ylva Johansson, who has been minister of employment back at home since 2014. A former maths, physics and chemistry teacher, she has worked as a minister in five different governments under three prime ministers.

And finally…

There is no UK nominee for the Commission, of course, given Brexit. Prime Minister Johnson has been spared the job of finding one, although nobody is quite sure how successful any nominee would have been anyway, given BoJo’s ability to lose MPs, brothers and, now, a Speaker of the House of Commons.

Current incumbent John Bercow is to depart his role either at the next election or on ‘Brexit Day’, 31 October, whichever is soonest. Last week, of course, the PM’s conflicted remain-favouring younger brother Jo Johnson announced he’s to resign as an MP and minister in a bid to, as the joke goes, spend less time with his family.

More and more Britons are being prescribed potentially addictive medicines like sleeping pills, opioids and other painkillers, raising the risk of a drug crisis like the one in the United States, health officials said on Tuesday (10 September),writes Kate Kelland of Reuters.

In a government-commissioned report, researchers at Public Health England (PHE) said evidence showed that “since at least 10 years ago more people are being prescribed more of these medicines and often for longer”.

In 2017 to 2018 alone, 11.5 million adults in England – more than a quarter of the adult population – was prescribed one or more of the medicines under review, the PHE analysis found.

The medicines included anti-anxiety drugs called benzodiazepines and sleeping pills known as z-drugs, as well as the epilepsy and anxiety medicines gabapentin and pregabalin, antidepressants, and opioid pain medicines.

Many of these can be addictive and could cause problems for people taking them or coming off them, PHE said. The report also found higher rates of prescribing to women and older people.

While prescribing of some drugs, like benzodiazepines and opioids, has dipped a little recently amid fears about the deadly opioid epidemic in the United States, others, such as the gabapentin, pregabalin, and some antidepressants, are being prescribed more often and for longer.

“This means more people are at risk of becoming addicted to them or having problems when they stop using them,” PHE said.

“It also costs the NHS (National Health Service) a lot of money, some of which is wasted because the medicines do not work for everyone all the time, especially if they are used for too long.”

An opioid epidemic in the United States has killed almost half a million Americans since 1999, and a report by the Organization for Economic Cooperation and Development (OECD) policy forum earlier this year warned that the United States “is by no means alone in facing this crisis.”

The Paris-based OECD said deaths linked to opioid use were rising sharply in Sweden, Norway, Ireland, and England and Wales.

Responding to the PHE report, Britain’s Medicines and Healthcare products Regulatory Agency said it is watching the US crisis closely and aiming to take avoiding action.

“We take the experience in the U.S. of dependence and addiction to opioids very seriously and are following developments to learn from the actions other countries are taking to tackle this issue,” it said in a statement.

Greetings! Of late, it’s been very difficult to write an EAPM update without referring at some point to Brexit. So we won’t stop now…. As most of you may now know, the pro-Remain brother of UK Prime Minister Boris Johnson has announced that he won’t stand at the next general election – although the word is that he’s not resigning straight away, thus avoiding the need for a by-election,writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Jo Johnson was science and education minister and, in a tweet, said he’s been “torn between family loyalty and the national interest –it’s an unresolvable tension & time for others to take on my roles as MP and minister”.

Scientists for the EU tweeted in response: “You were an excellent Minister of State for Universities and Science. You will be missed by the UK science community –a community that you understand well. We, in turn, understand this choice you made. You did the right thing.”

With Jo apparently not resigning as an MP straight away, this throws up the intriguing prospect of him being able to vote against his brother. Well, what’s the worst that can happen? He loses the Tory whip, he’s de-selected (he’s not standing anyway) and he may end up off the Downing Street Christmas card list.

The timing is quite incredible, and surely doesn’t help the prime minister. However, there’s still all to play for with the result, as ever, unpredictable.

What can be confidently predicted, though, is that a general election will be in the offing, certainly this year. All to play for…

Meanwhile, the Leader of the House of Commons,pro-Brexit Jacob Rees-Mogg caused ructions in Westminster when, under Parliamentary privilege, he called neurologist David Nicholl, who wrote the Yellow hammer Brexit–impact report for medicine supplies, “as irresponsible as Dr Wakefield”.

Andrew Wakefield is the discredited author of a notorious study wrongly linking the MMR jab to autism.

In response Chaand Nagpaul, who is chair of the British Medical Association council, said the comments were “utterly disgraceful and totally irresponsible”.

Chief Medical Officer Sally Davies meanwhile tweeted that she’d written to Rees-Mogg to express her “sincere disappointment” in his “disrespectful” comments, which went “too far” and were “frankly unacceptable”.

For his part, Nicholl said: “I challenge [Rees-Mogg] to repeat outside the chamber the allegation that I am comparable to Andrew Wakefield – let’s see what happens.”

Finally on Brexit for this ‘edition’, Lithuania’s new president, Gitanas Nausėda has said: “We try to make it an opportunity.”

“We are one of the most friendly countries to fintech companies,” Nausėda said, adding: “We’ve got about 150 companies from the UK and US–I can say it really works.”

He went on to say that: “Brexit with an agreement is the best solution. But the no-deal scenario looks quite realistic too.”

Shock EU ‘death’ figures

In a new survey, Eurostat tells us that, among people under 75, two-out-of–three deaths in the European Union could have been avoided in 2016.

It explains that 1.2 million from 1.7 million deaths could have been avoided. Many (741,000) through effective public health and primary interventions, and 422,000 deaths through timely and effective health-care interventions.

Such public health interventions ahead of heart and lung disease, as well as stroke, accounted for most of the avoidable deaths. More emphasis on prevention, anyone?

The ENVI of us all

The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) is back at work and has quickly proposed to carry out an in-depth review of the safety of vaccines.

The Petitions Committee heard six similar petitionsfrom Italy, all of which opposed the compulsory vaccination of children up to the age of 16.

One petitioner, Roberto Ionta, who is a prominent anti-vaccine campaigner, told the committee that Italian children are being “discriminated against” because they are excluded from school if they have not been vaccinated.

However, UK MEP Jude Kirton-Darling was against giving the anti-vaccination lobby too much time in the committee, saying: “I think there’s a grave danger that we feed and continue to feed a campaign of misinformation, which is actually putting all of our children at risk across the entire world.”

Its seems likely that the proposed study will land on the desk of the European Medicines Agency down the line.

Meanwhile, the committee discussed the EU Court of Auditors’ review of the bloc’s cross-border health-care efforts, which soon switched to medicines shortages, with French MEP Michèle Rivasi propounding the theory that some Europeans are engaging in cross-border travel to get medicines that are in short supply in their own country.

EAPM’s good friend Romania’s Cristian-Silviu Bușoi tied this in with crossing borders for orphan drugs. The Commission representative present, DG SANTE’s Ioana-Maria Gligor, reminded the MEP that the review of the EU’s orphan incentives is due later this year.

Peter Welch, directorof the ECA, explained that national contact points could give better information on rare diseases. The ECA’s recommendation is that the Commission should do more to support these, he added.

On cross-border exchange of health data, he said that the Commission has not achieved what it wanted, and that more member states are ready to receive data than are equipped to actually send it.

German MEP Tiemo Wölken (more of whom below) said that it is clear that goals are not being achieved, while Poland’s Sylwia Spurek quoted Eurostat figures on the small percentage of patients that takeadvantage of the cross-border health-care directive. The current system effectively discourages EU citizens getting health care in another state, she said.

Another EAPM champion, Malta’s Miriam Dalli said only a small amount of patients know their rights, and that action needs to be taken on an EU-wide basis. Miriam mentioned delays in information exchange and data exchange and asked how this can be addressed. The financing mechanism needs to be simpler, she said.

Meanwhile, on HTA, which rumbles on in Brexit-esque fashion, ENVI confirmed that the aforementioned Tiemo Wölken will be rapporteur for the health technology assessment brief.

Congratulations, Tiemo!

Incidentally, ENVI is now Parliament’s biggest panel, with 76 members. This is up from 64 in 2009 and 69 in 2014. Let’s hope that size does matter…

Health in brief

Sweden has said it will host an international high-level conference on antibiotic resistance monitoring, and the World Health Organization Global Resistance Monitoring System.

And in Germany, several top doctors’ groups have co-sent an open letter to Stern magazine warning that economics are overriding patients’ needs under the current accounting systems for hospitals and doctors’ offices.

Part of the letter reads: “It is negligent to leave hospitals and thus the fate of patients to the laws of the free market,” adding that patients’well-being should be the “most important goal.”

At the same time, the authors urged the government to abandon fixed-rate payments per patient because it would offer “many incentives to generate returns on unnecessary action to the detriment of patients”.

And finally…

It was revealed this week that scientists have found the first genetic instructions in human DNA that link to being left-handed.

The University of Oxford team say that left-handed people may have better verbal skills because the DNA instructions seem to be involved in the structure and function of the brain.

Roughly one-in-10 people are left-handed. For the record, Boris Johnson isn’t.

Greetings, all! Well, there’s never a dull moment with Brexit, is there? What with UK Prime Minister Boris Johnson facing a vote in the House of Commons on blocking a no deal, the launch of a massive ‘Get ready for Brexit’ campaign (undermined on the very same day by Michael Gove telling fibs about fresh food shortages – how can anyone ‘get ready’ if you don’t tell them the truth?), a general election probably in the offing, perhaps on 15 October, a Tory party parliamentary majority of zero due to one more defection, and The Queen probably scratching her head in Balmoral wondering what’s coming next,writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

One thing is certain – that the new prime minster received a reality check with a Commons defeat yesterday, with some MPs muttering that any no-deal Brexit policy also needs a sanity check.

As ever, more of that later…

Meanwhile, amid the relative sanity of Brussels (not a sentence we use often), incoming European Commission President Ursula von der Leyen has told German MEPs from her own EPP party that she’s considering changes to the EU’s competition policy rules. Another policy sanity check, perhaps?

It’s been reported that sources at the meeting heard her say she wants to “reconsider the definition of the market”.

It is strongly believed that Von der Leyen’s comments are a reaction to the incumbent Commission’s decision to block a merger between Germany’s Siemens and France’s Alstom’s earlier this year.

That putative deal was deemed “incompatible” with the internal market and it was feared it would harm competition.

In other Commission-related news, at the same meeting the president-elect said she will present her team of commissioners and their assigned portfolios “early next week”. This presumes that Italy will have made its mind up by then, of course. Von der Leyen is apparently expecting the name form Rome before the end of this week.

The incoming president seems confident of achieving gender parity among her new team, as well as colleagues who are balanced politically and geographically.

Of course, as we already know, central and eastern European countries don’t have any ofthe top jobs in Brussels. But she’ll attempt to address this by “highlighting” commissioners from the wider region, according to Politico, which “would happen via titles rather than portfolios”. That means vice-presidents, presumably.

Von der Leyen needs to move fairly quickly, now, as she’s running a bit late in respect of the European Parliament’s timetable. The latter expected the full list of nominees and relevant portfolios by the end of August.

The parliamentary hearings for would-be commissioners are due to take place between 30 September and 8 October, plus a bit of time added-on if any candidates are rejected.

With luck and a fair wind, the new Commission should be confirmed by 23 October, one week before it moves into the Berlaymont on 1 November.

Health matters

Austria is in the midst of an election campaign and, for once, healthcare has made an appearance during the run-in to the polls due at the end of September.

Pamela Rendi-Wagner, a physician and former health minister who is also the current leader of the Social Democrats, has said her party wants to reduce waiting times in doctors’offices.

“Long waiting times are inhuman,” she said, and also called for an expansion of the tasks of Austria’s health hotline. Those patients who call the hotline should receive an appointment right away and get the right doctor in respect of their needs.

This comes in the wake of former Austrian Chancellor Sebastian Kurz, the lead candidate of the centre-right Austrian People’s Party, stressing that improving the country’s nursing care insurance is one of his priorities.

Over in France, meanwhile, the country’s civil society watchdog Observatoire Transparence Médicaments wants the WHO to move from a “symbolic commitment for transparency” to something somewhat more concrete.

The Observatoire is releasing a recommended drug “transparency checklist” calling for more transparency on the price of medicines.

Among other items, the checklist calls for the creation of databases that would detail the price information. This would include prices paid by the relevant government, list prices, transaction prices and the reimbursement rate for medicines and medical devices.

On a broader note, and as clinical trials become more complex due to leaps in science, guidelines need to keep pace. Well, EAPM and its stakeholders have been saying this for years, of course.

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH, for short, mercifully) is busily revising its guidance for conducting clinical trials.ahead of a big get-together on 31 October at the US Food and Drug Administration’s offices near Washington DC.

In the meantime, the European Medicines Agency has urged EU regulators and other stakeholders to register to attend.

Back in Brussels, Health Commissioner Vytenis Andriukaitis recently stuck up for the Commission’s work on securing the supply of medicines across the EU.

Replying to Polish MEP Anna Fotyga, he highlighted that the Commission has worked to ensure continuous supply and is now looking at “possible additional ways to address shortages”.

The commissioner also struck a word-or-two of warning by writing that any deliberate withholding of supplies “may constitute an infringement of both European and national competition rules”.

We’re not sure how impressed hospital pharmacists in Luxembourg will be with the commissioner’s remarks. Probably ‘not very’ given that shortages have been a problem in the Duchy over the last five years.

Hospital pharmacists say they have consistently asked drug companies to give them warning in advance of anything in short supply, apparently to no avail.

RTL reported that this means pharmacists are “unable to prepare themselves, let doctors know about shortages, and clarify the issue to patients”.The Luxembourg Association of Hospital Pharmacists is adamant that there are critical communication issues on the side of suppliers.

All OK in UK?

Well, we know it isn’t. The current situation is a mess. But at least there’s some good news for Brits as the nation’s notified body BSIannounced it has given a CE mark to a medical device as conforming to the EU’s new regulations. For the first time. Ever.

BSI didn’t say what the product is or name the manufacturer,but the device in question moved to a new, higher risk category under the rules, and had to be re-certified before the May 2020 deadline.

NHS England, meanwhile, has announcedthat children diagnosed with a rare inherited eye disease that causes blindness will be eligible for treatment with a new gene therapy from January 2020.

NICE, which handles HTA, said in a statement that its cost-effectiveness evaluation of the expensive therapy was concluded in 20 weeks instead of the 38 weeks under its “highly specialized technology programme”.

Meindert Boysen, head of Health Technology Evaluation at NICE said that Novartis’ “willingness to work with us early and constructively has allowed us to publish this guidance on a much faster timeline than normal, which is good news for patients”.

Back to Brexit…Under an attempted parliamentary bill in Westminster, if there is no new deal, and no parliamentary consent for no deal by 19 October, Boris Johnson must request an extension to negotiations with the EU until 31 January, 2020.

Health-care think tanks should be pleased, as in an open letter to MPsthree of them – namely the King’s Fund, the Health Foundation and the Nuffield Trust – highlighted four areas where a no-deal Brexit would have a particularly nasty impact.

These are staffing, medicine and device shortages, caring for returners, and funding shortfalls.

In the instance of the medicine and device shortages, despite stockpiling and new supply routes, the think tanks say that extra red tape will increase import hurdles, as well as manufacturing costs, and forecasts that the already cash-strapped and under-staffed NHS will incur an estimated £2.3 billion in extra charges per year.

Meanwhile, the UK’s Office for Budget Responsibility has forecast that Britain’s public finances would be around £30 billion worse off each year in a no-deal scenario with medium disruptiveness.

Shadow Foreign Secretary Emily Thornberry has this week told MPs that she is seeking to access the government’s advice on what will happen to medicines that can’t be stockpiled, and whether the courts could rule that any people who die as a result of a lack of such medicinesdied as a result of government neglect.

Bordering on the ridiculous

Tom Black, chair of the British Medical Association in Northern Ireland, has stressed that no amount of reassurance from the Johnson government over the Irish border in a no-deal Brexit will prevent serious consequences for patients.

He says that, regardless of the UK’s stated intention not to return to a hard border, it’s in the EU’s interests to protect the single market if there’s no prior arrangement.

Black says that if a hard border returns, delays will inevitably have an impact on patients: “We know what a hard border looks like. Long queues of traffic, sometimes 10 hours.”

Meantime, Northern Ireland only has one medical school, while the Republic of Ireland has six. And with existing staff shortages in the National Health Service, “we need a continuing flow of these doctors from the Republic of Ireland to Northern Ireland”, Black said.

Worryingly, he also said that, with 750 million prescriptions a year in the UK across 7,500 different items coming from the EU, there will be “huge problems” for medicines supplies, especially those needing refrigeration such as insulin.

“If my patients had a problem I would send them to the Republic of Ireland to get a prescription,” he said, pointing out that the UK imports 100%of its human insulin from France and Denmark.

On top of this news, Martin McKee, who is professor of European public health at the London School of Hygiene and Tropical Medicine, has written in the British Medical Journal to flag-up the extent of health harm Brits can expect from Brexit.

The most immediate impacts, says McKee, will be increased suicide, homicide or violence, alcohol abuse, poor nutrition and an increase in communicable and non-communicable diseases.Wow!

Recent document leaks, meanwhile, show epilepsy and mental health medicines are most at risk of shortages.

And yet another report – this one from the UK in a Changing Europe research programme – states that a no-deal Brexit would push the UK towards a recession via a combination of barriers to trade with the EU, a falling pound and increased inflation.

And still, and still, Michael Gove stares the TV cameras (and broadcaster Andrew Marr) in the face and says that reports from the fresh food industry of inevitable shortages are false.

Greetings, and welcome to the latest update from EAPM, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Here at the Alliance we’re delighted to learn, via an announcement by Croatia’s Prime Minister Andrej Plenković, that current MEP Dubravka Šuica will be nominated as the country’s European commissioner.

Dubravka was a strong ally of all of us going into the Declaration of Cooperation on the one-million genomes project, so we’ll keep a close watch on developments and offer support where possible.

Rumour has it that Croatia is keen on the regional policy portfolio, so there may well be opportunities for our SMART Outlook programme. Either way, we congratulate Dubravka and look forward to meeting her at some point in her new role. As for the remaining MEPs, EAPM is already gearing up for effective action alongside the new intake and many faithful friends who are back in the hemicycle.

Meanwhile, back at the European Commission, the President-elect Ursula von der Leyen reportedly plans to start interviewing College candidates from next week.

Bulgaria has said it wants current Digital Commissioner Mariya Gabriel for the powerful agriculture dossier, whilevon der Leyen and French President Emmanuel Macron will discuss the French nominee for the Commission very soon (if not already), with an announcement of the candidate expected before 26 August.

Keeping genomics personal

Regarding genomic data (see the Alliance’s MEGA+ initiative, which aims to take the one-million genome further by adding all forms of healthcare data), a recent survey has taken a look at citizens’ views on their DNA and potentially sharing the resulting data.

Belgian charity The King Baudouin Foundation conducted a survey of 29,000 EU citizens, and it’s not particularly good news for pharmaceutical companies, given that only four in 10 respondents said they agree with the statement: “I’m willing to share my genetic information with pharmaceutical companies.”

Even worse, roughly one in four said they “strongly disagree”.

On the other hand, the sharing of genetic information with academic researchers is more popular, with 58% saying they would do that. Also, a hefty 73% said they want to know “as much as possible” about their DNA.

A focus group of 32 citizens, tied to the Foundation’s work, meanwhile indicated that people want to be able to make autonomous decisions via informed consent. However,they will need better information about genomic data, its implications and how it will be used.

Which highlights a need, of course, for new training for health care professionals and more options available from health systems when it comes to preventive care.

Defining ‘fair’

EAPM has often talked about the need for definitions in health care – not least regarding what constitutes ‘value’. Now we have a definition of ‘fair pricing’ in respect of medicines from the WHO.

The organization’s Fair Pricing Initiative says: “A fair price is one that is affordable for health systems and patients and that at the same time provides sufficient market incentive for industry to invest in innovation and the production of quality essential health products.”

But it wants to know whether or not you agree, or would change it instead. So head off to WHO’s survey, logging in with fair-pricing as the user name and 2019 as the password.

The survey also wants feedback on what proposed expert groups should focus on and what type of research they should generate.

Conditional reimbursement to continue?

Finland holds the current presidency of the EU, and its own health ministry wants,to all intents and purposes, to extend its experiment with conditional reimbursements in respect of some new medicines.

This is due to expire on 1 January 2020 but the talk now in Helsinki is of extending the programme until 2025.

Since 2017, Finland has approved 25 out of 33 drugs for conditional reimbursement, allowing them to work in real–world conditions before deciding whether the health system will pay. Parliament will decide on the new proposal in autumn.

Medtech moves in Germany

The German medtech lobby hopes to heap extra pressure on EU and national policymakers to deal with implementation issues around new medical device rules.

An article in a top German newspaper has put the spotlight on the plight of small manufacturers who are having problems complying with EU regulations brought in in 2017, and these small companies have a powerful voice – making up the majority of Germany’s €30 billion medtech industry.

Academics have blamed the rules for a drop in German medtech patent registrations since 2016.

Poles apart…

Given the recent kerfuffle over US President Donald Trump’s ideas on buying Greenland, the rebuff from Denmark, and Trump consequently throwing his teddy out of the pram and cancelling a visit to the country, a new joke is doing the rounds. It runs as follows:

“It’s not been widely reported, but Donald Trump also cancelled a trip to Warsaw…as he found out that neither the North nor South Poles were for sale.”

Boom!

Bad jokes aside, Trump hardly helped matters, either, when he accusedDanish Prime Minister Mette Frederiksen of disrespecting the US after she expressed “regret and surprise” over Trump’s decisionto cancel the Copenhagen visit, noting that preparations had been “well under way.”

OK, she had previously called Trump’s ideas over Greenland “absurd”, which really got the US President’s goat.

He told reporters: “I thought that the prime minister’s statement that it was ‘absurd,’ that it was an ‘absurd’ idea, was nasty. I thought it was an inappropriate statement.

“All she had to do is say, ‘No, we wouldn’t be interested…She’s not talking to me. She’s talking to the United States of America. You don’t talk to the United States that way – at least under me.”

In better news for EU-US relations, it turns out that the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have a high degree of alignment in marketing application decisions, more than 90%, in fact.

This was uncovered by a joint EMA/FDA analysis that compared decisions on 107 new medicine applications at the agencies from 2014–2016.

The study found that the most common reason for diverging decisions were differences in their conclusions about efficacy, followed by.differences in clinical data submitted in support of an application.

Zaide Frias, the head of EMA’s human medicines evaluation division, said: ”The high rate of convergence in the authorization of new medicines at EMA and the FDA is the result of expanded investment in dialogue and co-operation since 2003 and has fostered alignment between the EU and the US with respect to decisions on marketing authorisations, while both agencies evaluate applications independently of each other.”

She added: “Our co-operation clearly supports both agencies in achieving a common goal of maximizing patient access to safe, effective and high quality medicines in both regions.”

In the past ten years, the agencies have established joint working groups for sharing information and collaborating, using experts drawn from both the EU and US.

The latter spoke of“possibilities”when it comes to solving the Irish backstop problem and, thereby, avoiding a no-deal Brexit while at the same time making clear it was up to Britain to come up with a workable plan. Boris seemed to agree that the onus is, indeed, on the UK.

The timetable’s tight, though, with Berlin’s finest saying of any putative solution: “We can maybe find it in the next 30 days.”

France’s Macron, whom Johnson is scheduled to meet in Paris today (22 August) was less enthusiastic, and appeared to be ready to put the dampers on any such talk, given his lack of patience with the whole regrettable process.

He even went so far as to say that any trade deal between the UK and US will not compensate for the cost of Brexit, and would come at “the cost of a historic vassalization”.

“I don’t think it’s the will of the British people…to become the junior partner of the US,” Macron added.

Meanwhile, Irish EU Agriculture Commissioner Phil Hogan didn’t pull any punches when paraphrasing Winston Churchill in respect of the British handling of Brexit: “Never have so few done so much damage to so many,” he said.

Hogan is after the trade job at EU level warned that a no-deal Brexit would create a “foul atmosphere” between London and the rest of the EU that would have “serious consequences” for any future trade negotiations between the two.

Once Boris Johnson has met the French president, he’ll head to Biarritz for the G7 Summit followed by a meeting with European Council President Donald Tusk on Sunday (25 August) on the fringes of the gathering.

Back in Britain, of course, head of the UK Labour Party and official leader of the Opposition Jeremy Corbyn has called for a cross-party meeting of senior politicians, urging them to work with him to “do everything we can to stop” a no-deal Brexit.

He’s facing a struggle, as plenty have already said they don’t want Corbyn in Number Ten, even during any possible period of transition.

Let’s hope von der Leyen has better luck getting her College of Commissioners approved by the European Parliament. See you soon!

If you’re already on holiday, here’s hoping it’s proving to be an enjoyable one. And we promise not to keep you for too long.

The UK is due to leave the EU on the 31 October, as you will doubtless remember, and as we make our way through the summer months, that date looms ever larger.

Halloween is really not too far away – and the pumpkins and toffee apples are already popping up on the horizon.

Britain’s new prime minister Boris Johnson has not so much as popped up on the horizon, though, as stuck his head above a parapet. Tin hats anyone? We might all need one as the prospect of a no-deal departure is becoming ever-more likely.

Boris and co are demanding the removal of the Irish backstop as a precursor to any further talks. But this surely won’t happen, will it

Jonathan Powell was the UK’s chief negotiator on Northern Ireland from 1997-2007 and, in a recent article for the Financial Times, he made the following key point regarding Prime Minister Johnson: “There is no chance of the EU dropping the backstop as a precondition for meeting him, even if they were prepared to discuss it face to face.

“And, as long as the British government does not put forward a convincing alternative to deal with the threat posed to the Good Friday Agreement by Britain leaving the single market and the customs union and thereby recreating a hard border, the EU cannot back down.”

All seems quiet in Brussels. maybe too quiet. But there is currently no real sense of panic. Indeed, many feel that Boris will be thwarted in his do-or-die no-deal threat, possibly by a no-confidence vote that will force an election.

Meanwhile, the departure of one more Tory will leave him with no majority (it is currently just one, including Northern Ireland’s DUP).

In Wales, the sitting Conservative was last week deposed by a pro-remain Liberal Democrat, while in Scotland the latest opinion poll suggests that most Scots now favour independence, many of them because of the mess over Brexit.

On the other hand, in a no-deal departure, almost everything that the EU-27 doesn’t want to see happen on the island of Ireland probably will. But still no obvious jitters.

The main issue, of course, is the re-establishment of a hard border, although the UK says it won’t the ones to create one.

A British spokesman recently said: “Under no circumstances will we create a hard border in Northern Ireland or impose physical checks or infrastructure of any kind at the Northern Irish border.

“We are fully committed to upholding and protecting the Good Friday Agreement.”

The spokesman added: “The fact is the Withdrawal Agreement has been rejected three times and will not pass in its current form, so if the EU wants a deal, it needs to change its stance.”

The EU, at least on Monday (5 August), was unmoved, with the European Commission’s chief spokeswoman, Mina Andreeva, telling journalists that no one in Brussels envisages any positional change.

Andreeva added that: “In a no-deal scenario, the UK will become a third country very concretely without any transition arrangements.

“And that very obviously causes a significant disruption not only for citizens and businesses but also would have a serious economic impact, which would…have a proportionately higher impact in the United Kingdom than in the EU-27 member states.”

If no deal does go through, Irish officials will presumably be obliged to impose border inspections and customs duties on UK goods, as a direct result of WTO rules as well as the safeguarding of the integrity of the EU’s single market.

Medical supplies to Brits could suffer badly. As Politico has pointed out, France gets a lot of pharmaceuticals from the Netherlands, which could halt exports if there were doubts about the new interpretation of the single market in Ireland. So the goods wouldn’t reach Calais and the Channel Tunnel.

More than three years down the line and the situation is, if anything, becoming more rather than less complex. Halloween really could be a horror story for all concerned.

My body is a temple

Another Eurobarometer poll is just out and sees EU citizens citing “health and social security” as one of the three “most important issues” being faced in their particular country. The other two are unemployment and the rising cost of living.

Health and social security concerns top the charts in six nations, namely Finland (48%); Slovenia (47%); Hungary (45%); Portugal (34%); Latvia (32%); and, wait for it… the UK at 29%.

Ten countries rank health and social security in second place, with the highest proportions in Sweden (42%), Ireland (41%) and Denmark (40%).

Are you listening, politicians? Well let’s hope so as a further poll from Eurobarometer shows that, after this year’s European Parliament election, EU citizens have a rising trust in the bloc and increasing optimism about the EU’s future.

A record-busting number (56%) said they believed their “voice counts” in the EU. If ever there were a call to duty for MEPs, then that’s surely it.

As it turns out, the Brits have less faith in the EU than respondents from any other member state, with just 29% saying they tend to trust it. Meanwhile, generally, trust in the EU beats trust in national governments by about 10 percentage points.

The EU has bigged-up the poll results, saying: “Overall, the EU is seen in a more positive light than at any time over the past 10 years.”

HTA news

The EUnetHTA Executive Board has been busy and recently adopted the following “Understanding of EUnetHTA HTA”. Don’t you just love these terms? “Understanding.” OK…

This text was worked out over several months of consultation with the project’s board, and it explains that the EUnetHTA Executive Board agreed that HTA in the context of EUnetHTA activities is understood to be composed of the following elements:

• Assessments should inform decision-making

• Assessments are not decision-making processes themselves

• Information should be of relevance to a decision-maker or user of the assessment. Wording which is overly exclusionary has the potential to predetermine decision-making, and formulations such as “no conclusions can be drawn” should be avoided

• Assessments should include the best available evidence at a specific given time point

• Assessments should specifically formulate a ‘summary of findings’

• Summaries should endeavour to use clear and concise scientific language

So now you know.

Meanwhile, the Commission has followed up on the European Parliament’s legislative resolution on the proposal for a regulation on HTA and amending Directive 2011/24/EU.

In essence it says that it welcomes the overall positive approach set out in the resolution, adding that while waiting for the Council position, it reserves its position on the amendments of the European Parliament.

On that note, the Commission did express concerns over certain amendments. For those of you who are really keen, the issues arise in amendments 45, 49, 115, 116, 117, and 118. The Commission is also, it seems, a bit worried about Amendment 153.

And so the HTA proposals rumble on…

Europe needs to toughen up

A recent policy brief put together by Carl Bildt and Mark Leonard has the title: “From plaything to player: How Europe can stand up for itself in the next five years.”

In it, the authors point out that the last five years have not been kind to the European Union’s foreign policy.

“The EU has been less relevant, less active, and less united than was hoped in the heady days after the Lisbon Treaty came into force in 2010,” they write.

They add that the next five years “might be harder still”. This is because “the world is well on its way towards a new order based on geopolitical competition and the weaponization of global economic, cultural, and even climate linkages.”

“As the international situation descends into a miasma of geopolitical competition, Europeans are in danger of becoming hapless playthings in a tussle for pre-eminence between China, Russia, and the United States,” they add.

Just to really cheer us all up, Bildt and Leonard state that the EU’s foreign policy is inadequate to the task of keeping Europe safe in today’s world of great power politics and uncertainty.

They add that trust between Brussels and member states dwindled, and policy came to reflect the lowest common denominator of popular opinion.

Looking ahead, they feel that the next five years “herald acute pressure on Europe, particularly as Russia, China, and the US undermine multilateral institutions and treat trade, finance data, and security guarantees as instruments of power rather than global public goods”.

They suggest that the new high representative should move quickly to rewire European foreign policymaking to exercise strategic sovereignty, noting that the high representative needs more support on this strategy.

In a clear message to Ursula von der Leyen’s incoming Commission, Bildt and Leonard say that the new leadership team in Brussels needs to re-operationalise European defence, build Europe’s self-sufficiency through a strong European pillar in NATO, and consider innovations such as a European Security Council.

“Europe will only build greater unity by tackling controversial issues head on in the European Council and the Foreign Affairs Council. The high representative needs to play a much more active role in these debates,” they say.

All of that should certainly keep von der Leyen, the former German defence minister, pretty busy going forward.

Meanwhile, we wish you good health and happy holidays.

About EAPM

The European Alliance for Personalised Medicine brings together Europe’s leading healthcare experts and patient advocates to improve patient care by accelerating the development, delivery and uptake of personalised medicine and diagnostics.

It is calling for the European Commission, the European Parliament and EU member states to help improve the regulatory environment so that patients can have early access to personalised medicine, and so that research is boosted.